MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INFLUENZA A/B 2.0 (24T); INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY

Catalog Number	427-000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: 9 years and 4 months old d2a - common device name: influenza a and influenza b multiplex nucleic acid assay; real time nucleic acid amplification system; respiratory virus panel nucleic acid assay system an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a false negative result with the id now influenza a/b 2.0 assay performed on (b)(6) 2025 on a nasal sample.The patient was sent home without treatment.The patient was reported to have started experiencing symptoms that day, and they worsened following the office visit.Four hours later, the patient went to the emergency room, where confirmation pcr (unknown platform) testing was performed generating a positive result.The patient was reported to be experiencing the following symptoms at home, prior to the emergency room visit: hypoxia, respiratory distress, difficulty breathing, and shortness of breath.The patient was hospitalized and received treatment (unknown type).Although requested, no additional information including patient outcome was provided.
Additional Manufacturer Narrative
A2 - age at time of event: 9 years and 4 months old.D2a - common device name: influenza a and influenza b multiplex nucleic acid assay; real time nucleic acid amplification system; respiratory virus panel nucleic acid assay system testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000m919576 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 427-000/ lot 000m919576, test base part number 427-430/ lot 000m919576.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 000m919576 showed that the complaint rate is (b)(4)%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
Event or Problem Description
The customer reported a false negative result with the id now influenza a/b 2.0 assay performed on (b)(6) 2025 on a nasal sample.The patient was sent home without treatment.The patient was reported to have started experiencing symptoms that day, and they worsened following the office visit.Four hours later, the patient went to the emergency room, where confirmation pcr (unknown platform) testing was performed generating a positive result.The patient was reported to be experiencing the following symptoms at home, prior to the emergency room visit: hypoxia, respiratory distress, difficulty breathing, and shortness of breath.The patient was hospitalized and received treatment (unknown type).Although requested, no additional information including patient outcome was provided.

• Brand Name: ID NOW INFLUENZA A/B 2.0 (24T)
• Common Device Name: INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 21567762
• Report Number: 1221359-2025-00087
• Device Sequence Number: 11855915
• Product Code: OZE
• UDI-Device Identifier: 10811877010422
• UDI-Public: (01)10811877010422(17)260612(10)000M919576
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Catalogue Number: 427-000
• Device Lot Number: 000M919576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 9 YR
• Patient Sex: Unknown